Biodel Inc. (BIOD) reported third-quarter fiscal 2013 loss of 66 cents per share, wider than the year-ago loss of 52 cents and the Zacks Consensus Estimate of 37 cents per share.
Biodel did not generate revenues in the reported quarter and also in the year-ago comparable quarter.
Research and development (R&D) expenses increased 20% to $3.6 million due to costs incurred on a phase II study on BIOD-123.
Biodel has finished dosing patients in the phase II randomized, open label, parallel group study conducted across approximately 33 U.S. sites. Approximately 132 patients suffering from type I diabetes were randomized to receive either BIOD-123 or Eli Lilly and Company’s (LLY) Humalog as meal-time insulin during the therapy duration of 18 weeks. In the study, the primary endpoint is HbA1c control. The secondary endpoints are postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes.
Biodel expects to report top-line data from the study in the third quarter of calendar 2013.
Meanwhile, Biodel presented encouraging data from a phase I study on its two insulin Lispro-based formulations, BIOD-238 and BIOD-250, at the American Diabetes Association. Both candidates showed a significantly more rapid rate of absorption compared to Humalog and also compared favorably to Humalog where injection site tolerability is concerned.
Biodel made a strategic move during the reported quarter for its Glucagon program by entering into a 15-year supply agreement with Unilife Corporation (UNIS). Under the agreement, Biodel acquired exclusive worldwide rights to Unilife’s proprietary auto reconstitution technology from the EZMix platform of dual chamber devices for use with Glucagon for the treatment of severe hypoglycemia in diabetics.
General and administrative expenses decreased by 5.6% to $1.7 million.
Currently, Biodel carries a Zacks Rank #3 (Hold). Companies like Gilead Sciences Inc. (GILD) look well-positioned with a Zacks Rank #1 (Strong Buy).
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